Prospective Dynamic Cohort Study of Phenotypic Profiles in Patients With Chronic Obstructive Pulmonary Disease

Официальное название

Prospective Multicenter Dynamic Cohort Study to Evaluate Phenotypic Profiles of Subjects With Chronic Obstructive Pulmonary Disease (COPD-BPCO 2 Study)

Обзор

This prospective, multicenter, real-world observational cohort study will describe phenotypic profiles, patient characteristics, and treatments in adults with stable chronic obstructive pulmonary disease (COPD). The profiles observed in the current cohort will be compared with those of patients recruited between 2005 and 2018 in the previous COPD-BPCO 1 cohort. Patients will be followed for at least 3 years as part of routine care, with no study-specific visit or treatment.

Подробное описание

COPD is a heterogeneous disease, and patient characteristics may be associated with prognosis and treatment response. The previous Initiative BPCO cohort recruited 1,720 subjects between 2005 and 2018 and identified clinically relevant COPD phenotypes, including subgroups associated with mortality risk. Because diagnostic strategies, risk factors, comorbidity management, and COPD treatments have evolved, this new prospective dynamic cohort will assess whether current COPD phenotypes differ from those previously identified and whether classification and regression tree (CART) algorithms developed in the previous cohort remain applicable. Data will be collected during routine care from hospital pulmonology centers in France. Baseline and follow-up data may include demographics, risk factors, comorbidities, usual treatments, patient-reported questionnaires, pulmonary function, arterial blood gases, 6-minute walk test, imaging, biology results, exacerbations, and mortality status.

Вмешательства

• Другое Routine care / no study-specific intervention
  Patients will be managed according to usual care at the investigator's discretion. The study does not assign any treatment, medicinal product, or medical device.

Первичные конечные точки

• Identification and description of COPD phenotypic profiles [Срок оценки: Baseline and up to 3 years]

Вторичные конечные точки (4)

• Comparison of phenotypic profiles with the previous COPD-BPCO 1 cohort [Срок оценки: Current profiles will be compared with those observed in the previous cohort recruited between 2005 and 2018.]
• Prognosis of current patients compared with the previous cohort [Срок оценки: 3 years]
• Applicability of previously developed CART algorithms [Срок оценки: Through study completion, an average of 3 years]
• Adverse events [Срок оценки: Through study completion, an average of 3 years]

Критерии участия

Критерии включения

Age 18 years or older.

• Stable COPD, defined as no exacerbation requiring treatment during the previous 4 weeks.
• Confirmed COPD diagnosis based on post-bronchodilator FEV1/FVC < 70%

Критерии исключения

• Main diagnosis of bronchiectasis, asthma, or any other significant respiratory disease.
• Patients under legal protection.
• Pregnant women.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 7 центров

• Chu Bordeaux — Bordeaux
• Chu Lille — Lille
• Chu Lille — Lille
• Chu Nancy-Brabois — Nancy
• Hopital Cochin — Paris
• Chu Reims — Reims
• Chu Saint Etienne — Saint-Etienne

Идентификаторы

NCT: NCT07627763 · 2024-A00438-39 / COPD-BPCO 2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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